Choice of Modality of Follow up for Medication Abortion

Not Applicable

Terminated

• Conditions: Abortion in First Trimester
• Interventions: Other: Choice of follow-up option; Device: Multi-level pregnancy test

• Registration Number: NCT04056637
• Lead Sponsor: Stanford University

Brief Summary

This study will assess the impact of providing medication abortion-seeking clients a choice for follow-up in practice. Clients presenting at or less than 63 days pregnant (based on last menstrual period) at the study site for first trimester medication abortion will be invited to participate. We hypothesize that providing clients with flexible follow-up options will improve follow-up rates.

This study is not to assess efficacy or safety of follow-up methods--that has been well established in practice and research. This is to assess choice of follow-up.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-14
• Study Start: 2019-09-09
• Primary Completion: 2020-03-13
• Study Completion: 2020-03-31
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-26
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 26

Inclusion Criteria

• Eligible for medication abortion <63 days gestational age
• In general good health
• English or Spanish speaking competency
• Willing and able to sign consent forms

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Exclusion Criteria

• Clients less than 18 years of age.
• Any client not meeting the inclusion criteria listed above will be excluded from participating in the trial.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Flexible Follow-Up	Choice of follow-up option	Participants will be offered three follow-up options, including: 1) follow-up in clinic 1-2 weeks following mifepristone administration for an ultrasound and consultation with a provider; 2) repeat serum beta-hCG testing; 3) repeat multi-level pregnancy test strategy
Group 2: Flexible Follow-Up	Multi-level pregnancy test	Participants will be offered three follow-up options, including: 1) follow-up in clinic 1-2 weeks following mifepristone administration for an ultrasound and consultation with a provider; 2) repeat serum beta-hCG testing; 3) repeat multi-level pregnancy test strategy

Primary Outcome Measures

Name	Time	Method
Percent follow-up after medication abortion by group	5-14 days following mifepristone administration	To compare rates of follow-up among clients who are instructed to come back to the clinic for in-person ultrasound medication abortion follow-up to clients who are given options for follow-up, including in-person ultrasound, repeat serum beta-hCG and MLPT

Secondary Outcome Measures

Name	Time	Method
Percent follow-up after medication abortion by follow-up type	5-14 days following mifepristone administration	To compare the overall proportion of follow-up completion among clients choosing their preferred method of follow-up (in-person ultrasound, repeat serum beta-hCG, MLPT strategy) (study period) to clients given only the option for in-person follow-up

Trial Locations

Locations (1)

Stanford Health Care; 🇺🇸 Stanford, California, United States